March 2026 FDA Recall Furosemide by Leading Pharma, Llc (D-0486-2026 - CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.)
This Class II drug recall was voluntarily initiated by Leading Pharma, Llc on March 20, 2026 for the product Furosemide. The FDA reported the reason for recall as cgmp deviations; presence of n-nitroso-furosemide (nnf) above the recommended intake limit.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0486-2026
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
03-20-2026
04-29-2026
9384 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Leading Pharma, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: Leading Pharma, LLC, Fairfield, NJ 07004, NDC 69315-118-01
Batch or Lot Expiration Information
Lot# Lots# H03125, H03225, H03325, Exp Date: 2027/08
